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: Pulpal Blood Flow With the Use of Intra-nasal Anesthetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368391
Recruitment Status : Unknown
Verified December 2017 by Janice Townsend, Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Janice Townsend, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
Anesthetics with vasoconstrictors decrease pulpal blood flow but the impact of intranasal local anesthetics on blood flow is unknown. This blinded, randomized crossover clinical trial will compare the effects of different local anesthetics on anterior teeth in healthy volunteers. On separate study visits patients will receive either traditional injections or intranasal administration of the following solutions: 2% lidocaine with 1:100,000 epi, 3% mepivacaine, tetracaine HCl and oxymetazoline HCl, or saline. The following variables will be assessed: pulpal blood flow, pulpal sensibility, pain on administration, and adverse outcomes.

Condition or disease Intervention/treatment Phase
Local Anesthetic Drug Adverse Reaction Local Infiltration Pulp Disease, Dental Drug: tetracaine HCl and oxymetazoline HCL Drug: 2% Lidocaine with 1:100,000 epinephrine Drug: 3% Mepivacaine with 1:100,000 epinephrine Drug: saline intranasal Drug: saline infiltration Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: triple blinded cross over randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: the dentist who administered the study medications will know their identity but the participant, investigator who tests the teeth, and person calling for later outcomes will not know.
Primary Purpose: Other
Official Title: Pulpal Blood Flow With the Use of Intra-nasal Anesthetic: a Randomized Double-blind Crossover Study
Estimated Study Start Date : January 3, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Sequence 1

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.

Sequence 1 participants will receive the drugs in the following sequence: 1) tetracaine HCl and oxymetazoline HCl 2) 3% mepivacaine 3) 2% lidocaine with 1:100,000 epi

Drug: tetracaine HCl and oxymetazoline HCL
0.4 mL HCl and oxymetazoline HCl administered intranasally

Drug: 2% Lidocaine with 1:100,000 epinephrine
2.5 mL of 2% Lidocaine with 1:100,000 epi will be infiltrated at anterior teeth

Drug: 3% Mepivacaine with 1:100,000 epinephrine
2.5 mL of 3% Mepivacaine will be infiltrated at anterior teeth

Drug: saline intranasal
0.4 mL intranasal saline will be administered as a placebo

Drug: saline infiltration
2.8 mL of saline will be infiltrated at anterior teeth as a placebo

Sequence 2

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.

Sequence 2 participant will receive the drugs in the following sequence: 1) 2% lidocaine with 1:100,000 epi 2) tetracaine HCl and oxymetazoline HCl 3) 3% mepivacaine

Drug: tetracaine HCl and oxymetazoline HCL
0.4 mL HCl and oxymetazoline HCl administered intranasally

Drug: 2% Lidocaine with 1:100,000 epinephrine
2.5 mL of 2% Lidocaine with 1:100,000 epi will be infiltrated at anterior teeth

Drug: 3% Mepivacaine with 1:100,000 epinephrine
2.5 mL of 3% Mepivacaine will be infiltrated at anterior teeth

Drug: saline intranasal
0.4 mL intranasal saline will be administered as a placebo

Drug: saline infiltration
2.8 mL of saline will be infiltrated at anterior teeth as a placebo

Sequence 3

All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.

Sequence 3 participants will receive the drugs in the following sequence: 1) 3% mepivacaine 2) 2% lidocaine with 1:100,000 epi 3) tetracaine HCl and oxymetazoline HCl

Drug: tetracaine HCl and oxymetazoline HCL
0.4 mL HCl and oxymetazoline HCl administered intranasally

Drug: 2% Lidocaine with 1:100,000 epinephrine
2.5 mL of 2% Lidocaine with 1:100,000 epi will be infiltrated at anterior teeth

Drug: 3% Mepivacaine with 1:100,000 epinephrine
2.5 mL of 3% Mepivacaine will be infiltrated at anterior teeth

Drug: saline intranasal
0.4 mL intranasal saline will be administered as a placebo

Drug: saline infiltration
2.8 mL of saline will be infiltrated at anterior teeth as a placebo




Primary Outcome Measures :
  1. Change in Pulpal Blood Flow [ Time Frame: baseline and 7, 12, 17, 32, 47, and 62 minutes after administration of anesthetics ]
    change in pulpal blood flow will be measured using doppler flowmetry


Secondary Outcome Measures :
  1. Pulp sensibility [ Time Frame: baseline before administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  2. Pulp sensibility [ Time Frame: 5 minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  3. Pulp sensibility [ Time Frame: 10 minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  4. Pulp sensibility [ Time Frame: 15 minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  5. Pulp sensibility [ Time Frame: 30 minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  6. Pulp sensibility [ Time Frame: 45minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  7. Pulp sensibility [ Time Frame: 60 minutes after administration of anesthetics ]
    pulp sensibility will be measured by a electrical pulp testing unit

  8. Pain [ Time Frame: baseline before administration of local anesthetics ]
    pain utilizing Heft Parker Pain Scale

  9. Pain [ Time Frame: immediately after administration of local anesthetics ]
    pain utilizing Heft Parker Pain Scale

  10. Pain [ Time Frame: 1 hour after administration of local anesthetics ]
    pain utilizing Heft Parker Pain Scale

  11. Pain [ Time Frame: 4 hours after administration of local anesthetics ]
    pain utilizing Heft Parker Pain Scale

  12. Pain [ Time Frame: 24 hours after administration of local anesthetics ]
    pain utilizing Heft Parker Pain Scale

  13. adverse outcomes [ Time Frame: immediately after administration of local anesthetics ]
    A list of potential complications will be given to patients and they will check the ones that will apply. This is qualitative not quantitative data so units are not relevant.

  14. Adverse outcomes [ Time Frame: 1 hour after administration of local anesthetics ]
    A list of potential complications will be given to patients and they will check the ones that will apply. This is qualitative not quantitative data so units are not relevant.

  15. Adverse outcomes [ Time Frame: 4 hours after administration of local anesthetics ]
    A list of potential complications will be given to patients and they will check the ones that will apply. This is qualitative not quantitative data so units are not relevant.

  16. Adverse outcomes [ Time Frame: 24 hours after administration of local anesthetics ]
    A list of potential complications will be given to patients and they will check the ones that will apply. This is qualitative not quantitative data so units are not relevant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1 or 2 with no contraindications to the medications in this study
  • no restorations on the anterior teeth, no sign of history of dental trauma, and a normal periodontium to be included

Exclusion Criteria:

  • known hypersensitivity to tetracaine, benzyl alcohol ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, lidocaine, and mepivacaine -inadequately controlled hypertension or thyroid disease, frequent nose bleeds, or history of methemoglobinemia will not be eligible. Patients taking monoamine oxidase inhibitors are not eligible as well. Pregnant women will not be eligible as a precaution.
  • Subjects will be excluded if they have restorations, traumatic occlusion, orthodontic appliance, pathologic discoloration of dentition, fixed retainer on maxillary anterior, resorption, pulp canal obliteration, previous endodontic therapy, history of trauma to maxillary anterior dentition, or a fractured tooth structure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368391


Contacts
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Contact: Janice A Townsend, DDS, MS 504-941-8250 jtown2@lsuhsc.edu
Contact: Scott Thayer, DDS 504-941-8199 sthaye@lsuhsc.edu

Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Janice A Townsend, DDS, MS LSUHSC School of Dentistry
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Responsible Party: Janice Townsend, Associate Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03368391    
Other Study ID Numbers: 9924
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dental Pulp Diseases
Stomatognathic Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Tooth Diseases
Lidocaine
Phenylephrine
Epinephrine
Racepinephrine
Oxymetazoline
Tetracaine
Mepivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents